Effect of grape juice intake on inflammatory response in overweight women.

Effect of grape juice ingestion on microRNA expression in plasma and mononuclear cells in overweight women.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

REBEC

Registry ID

RBR-786v9gq

Enrollment

Unknown

Registered

2021-02-05

Start date

2017-08-18

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight women

Interventions

Experimental group: 20 overweight women received 500 mL of grape juice per day for 4 weeks. There was no control group. The intervention started after the first data collection (anthropometric, physic

G07.203.650.283

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Women between eighteen and forty years old; BMI between twenty-five and twenty-nine and nine kg/m² and be willing to adhere to the study protocol and sign the informed consent form (ICF).

Exclusion criteria

Exclusion criteria: Men; age under eighteen or over forty years old; BMI less than twenty-five kg/m² or greater than twenty-nine and nine kg/m²; be an athlete; diagnosis of diabetes mellitus; use medication to control inflammation, plasma lipid profile or systemic blood pressure; make use of vitamin supplements, probiotics, prebiotics, symbiotics, antibiotics or any other medication that may interfere with the intestinal microbiota; habit of frequently consuming grape juice; alcohol consumption in seven days prior to the study; smoker; presence of any chronic gastrointestinal disease (for example, inflammatory bowel disease, celiac disease, cancer); pregnant and or participating in another study.

Design outcomes

Primary

Measure	Time frame
Primary endpoint 1: Check modulation of microRNA expression related with inflammation by real-time PCR, being expected 95% of problaby confiance probability test. ;Primary endpoint 2: Check modulation of the concentration of inflammation-related biomarkers by ELISA method, being expected 95% of problaby confiance probability test.;Primary endpoint 3: Check modulation of intestinal microbiota and metabolism.	—

Measure

Time frame

Primary endpoint 1: Check modulation of microRNA expression related with inflammation by real-time PCR, being expected 95% of problaby confiance probability test. ;Primary endpoint 2: Check modulation of the concentration of inflammation-related biomarkers by ELISA method, being expected 95% of problaby confiance probability test.;Primary endpoint 3: Check modulation of intestinal microbiota and metabolism.

—

Secondary

Measure	Time frame
Secondary endpoint 2: Check a improvement of lipid profile by colorimetric analysis, being expected 95% of problaby confiance probability test. ;Secondary endpoint 2: Check a improvement of blood glucose by colorimetric test, being expected 95% of problaby confiance probability test.	—

Countries

Brazil

Contacts

Public ContactMarcelo TAGLIETTI

marcelotaglietti@gmail.com4532291558

Outcome results

None listed

Source: REBEC (via WHO ICTRP)